Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Reported: June 28, 2017 Initiated: March 21, 2017 #Z-2611-2017
Product Description
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
Reason for Recall
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 19, 927.00
- Distribution
- Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa
- Location
- Newark, DE
Frequently Asked Questions
What product was recalled? ▼
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 19, 927.00.
Why was this product recalled? ▼
The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 28, 2017. Severity: Moderate. Recall number: Z-2611-2017.
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